Optimizing peritoneal dialysis using a patient hand-held scanning device

ABSTRACT

A handheld personal communication apparatus for dialysis includes: a reader to (i) read a marking displayed on a dialysis fluid container to acquire data concerning at least one of a dialysis fluid type or a dialysis fluid volume from the marking, and/or (ii) receive a patient weight signal from a weight scale; a processor using at least one of the dialysis fluid type, dialysis fluid volume, or patient weight to determine a dialysis dwell time for at least one cycle of a dialysis therapy, the dialysis dwell time being a time to achieve, over the at least one cycle, at least one of (a) a specified ultrafiltrate level, (b) a urea removal level, or (c) a creatinine removal level; and an output interface providing an indication to the patient of a completion of the dialysis dwell time.

PRIORITY CLAIM

This application is a continuation of U.S. patent application Ser. No.12/826,183, filed Jun. 29, 2010, now U.S. Pat. No. 9,020,827, whichclaims priority to and the benefit of U.S. Provisional PatentApplication Ser. No. 61/252,363, filed Oct. 16, 2009, the entirecontents of each of which are hereby incorporated by reference andrelied upon.

BACKGROUND

The present disclosure relates to medical fluid delivery and inparticular to a peritoneal dialysis (“PD”) therapy.

Due to various causes, a person's renal system can fail. Renal failureproduces several physiological impairments and difficulties. The balanceof water, minerals and the excretion of daily metabolic load is nolonger possible and toxic end products of nitrogen metabolism (urea,creatinine, uric acid, and others) can accumulate in blood and tissue.Kidney failure and reduced kidney function have been treated withdialysis. Dialysis removes waste, toxins and excess water from the bodythat would otherwise have been removed by normal functioning kidneys.Dialysis treatment for replacement of kidney functions is critical tomany people because the treatment is life saving.

Hemodialysis and peritoneal dialysis are two types of dialysis therapiesused commonly to treat loss of kidney function. A hemodialysis (“HD”)treatment utilizes the patient's blood to remove waste, toxins andexcess water from the patient. The patient is connected to ahemodialysis machine and the patient's blood is pumped through themachine. Catheters are inserted into the patient's veins and arteries sothat blood can flow to and from the hemodialysis machine. The bloodpasses through a dialyzer of the machine, which removes waste, toxinsand excess water from the blood. The cleaned blood is returned to thepatient. A large amount of dialysate, for example about 120 liters, isconsumed to dialyze the blood during a single hemodialysis therapy.Hemodialysis treatment lasts several hours and is generally performed ina treatment center about three or four times per week.

Peritoneal dialysis uses a dialysis solution, also called dialysate,which is infused into a patient's peritoneal cavity via a catheter. Thedialysate contacts the peritoneal membrane of the peritoneal cavity.Waste, toxins and excess water pass from the patient's bloodstream,through the peritoneal membrane and into the dialysate due to diffusionand osmosis, i.e., an osmotic gradient occurs across the membrane. Thespent dialysate is drained from the patient, removing waste, toxins andexcess water from the patient. This cycle is repeated.

There are various types of peritoneal dialysis therapies, includingcontinuous ambulatory peritoneal dialysis (“CAPD”), automated peritonealdialysis (“APD”), tidal flow APD and continuous flow peritoneal dialysis(“CFPD”). CAPD is a manual dialysis treatment. The patient manuallyconnects an implanted catheter to a drain, allowing spent dialysatefluid to drain from the peritoneal cavity. The patient then connects thecatheter to a bag of fresh dialysate, infusing fresh dialysate throughthe catheter and into the patient. The patient disconnects the catheterfrom the fresh dialysate bag and allows the dialysate to dwell withinthe peritoneal cavity, wherein the transfer of waste, toxins and excesswater takes place. After a dwell period, the patient repeats the manualdialysis procedure, for example, four times per day, each treatmentlasting about an hour. Manual peritoneal dialysis requires a significantamount of time and effort from the patient, leaving ample room forimprovement. There is room for improvement in the selection of dwelltimes for each patient.

Automated peritoneal dialysis (“APD”) is similar to CAPD in that thedialysis treatment includes drain, fill, and dwell cycles. APD machines,however, perform the cycles automatically, typically while the patientsleeps. APD machines free patients from having to manually perform thetreatment cycles and from having to transport supplies during the day.APD machines connect fluidly to an implanted catheter, to a source orbag of fresh dialysate and to a fluid drain. APD machines pump freshdialysate from a dialysate source, through the catheter, into thepatient's peritoneal cavity, and allow the dialysate to dwell within thecavity, and allow the transfer of waste, toxins and excess water to takeplace. The source can be multiple sterile dialysate solution bags.

APD machines pump spent dialysate from the peritoneal cavity, though thecatheter, to the drain. As with the manual process, several drain, filland dwell cycles occur during APD. A “last fill” occurs at the end ofCAPD and APD, which remains in the peritoneal cavity of the patientuntil the next treatment. Both CAPD and APD are batch type systems thatsend spent dialysis fluid to a drain. Tidal flow systems are modifiedbatch systems. With tidal flow, instead of removing all of the fluidfrom the patient over a longer period of time, a portion of the fluid isremoved and replaced after smaller increments of time.

Continuous flow, or CFPD, systems clean or regenerate spent dialysateinstead of discarding it. These systems pump fluid into and out of thepatient, through a loop. Dialysate flows into the peritoneal cavitythrough one catheter lumen and out another catheter lumen. The fluidexiting the patient passes through a reconstitution device that removeswaste from the dialysate, e.g., via a urea removal column that employsurease to enzymatically convert urea into ammonia. The ammonia is thenremoved from the dialysate by adsorption prior to reintroduction of thedialysate into the peritoneal cavity.

In each of the kidney failure treatment systems discussed above, it isimportant to control ultrafiltration, which is the process by whichwater (with electrolytes) moves across a membrane, such as a dialyzer orperitoneal membrane. For example, ultrafiltration in peritoneal dialysisis a result of transmembrane and osmotic pressure differences betweenblood and dialysate across the patient's peritoneal membrane. It is alsoimportant to control the concentration of metabolic substances in thepatient's bloodstream, such as urea concentration, β₂-microglobulin,creatinine concentration, and so forth. Each of these, along with manyother variables, constitutes a peritoneal dialysis outcome.

Each patient is different, possessing for instance, a unique peritonealmembrane, its own separation characteristics, and its unique response toperitoneal dialysis. Each patient is also different with respect to bodysurface area (“BSA”) and total body water volume, which also have aneffect on transport characteristics. Each patient is different in termsof transport characteristics that relate to the ultrafiltration rate.Each patient is also different in terms of response to dialysis, thatis, the amount of water and waste removed in a given time period, usinga given fill volume, a particular dialysis fluid, and so forth. What isneeded is a way to better control the particular dialysis therapyoffered to each patient, so that the treatment will yield the besttherapy outcome for that patient, for one or more dialysis inputparameters

While APD frees the patient from having to manually performing thedrain, dwell, and fill steps, a need still exists for CAPD. Somepatients prefer the control that CAPD offers. Since the patient is awakeduring CAPD, the patient can adjust himself/herself during drain toproduce more complete drains. Further, many patients who perform APDalso perform a midday exchange using a CAPD technique.

In optimizing the therapy for both APD and CAPD, the dwell periodbecomes important. If spent dialysate is permitted to dwell in thepatient's peritoneal cavity too long, solutes and water that have beenremoved from the patient into the dialysate can reenter the patient'sbody. It is accordingly desirable to provide an apparatus and methodthat prevents such a situation from occurring.

SUMMARY

The present disclosure provides a system, method and device foroptimizing a peritoneal dialysis therapy and in particular a dwellperiod during which a dialysis fluid or solution, sometimes termeddialysate, is allowed to dwell within the patient's peritoneal cavity.As discussed in the BACKGROUND, if the dialysis fluid is allowed todwell too long within the patient, solutes and water that the dialysisfluid has removed can reenter the patient. On the other hand, thedialysis fluid should be allowed to dwell within the patient until it isused fully or until the osmotic gradient provided by the dialysis fluidis fully spent.

The present disclosure sets forth systems, methods and apparatuses forselecting a dwell time for peritoneal dialysis based on an individualpatient's response to dialysis, and also based on one or more peritonealdialysis input parameters. The dwell time is selected to yield themaximum fluid toxin (e.g. urea, creatinine) removal for that patientbased on the dialysis parameters. The embodiments set forth herein allowthe optimal dwell time to be determined based on patient's transporttype, gender, height, fill volume and dialysate type, for example. Thesystem alerts the patient to the optimal dwell time. The alert signalsto the patient when to drain the spent dialysate to achieve optimalclearance and ultrafiltration (“UF”) removal.

The system also logs the treatment information and makes suchinformation available to a doctor or clinician, so that (i) theeffectiveness of the patient's prescription and (ii) the patient'scompliance can be identified and monitored, and (iii) the patient'stherapy prescription can modified if needed. In this manner, the systemand method of the present disclosure optimizes the patient's treatmenton a local (therapy) level and on integrated (e.g., monthly visits todoctor or clinician) level.

In one embodiment, the system includes a portable reader, such as keyring, key fob, necklace or device that can be worn on a patient,patient's belt or be carried in the patient's pocket. The portablereader includes an optical scanner, such as a barcode scanner, awireless receiver or reader, such as a radio-frequency (“RFID”) orBluetooth™ receiver, an output device, such as an audio, visual,mechanical or audiovisual output device, processing and memory. Thepatient holds the portable reader next to a marking on the dialysisfluid supply container or bag. The marking can for example be a barcodeor RFID tag. The barcode identifies the solution type (e.g. dextroselevel and/or other chemical characteristics) and/or the solution volume.The wireless receiver of the portable reader also receives the patient'spre-therapy weight from a weigh scale configured to weigh the patientand send a weight signal, e.g., wirelessly via patient Bluetooth™emitter to the receiver. Alternatively or additionally, wirelessreceiver of the portable reader also receives the patient's pre-therapyblood pressure from a blood pressure cuff or bioimpedance measurementform a bioimpedance device.

The processing and memory receive the solution and use an algorithm todetermine the optimal dwell period, which the output device thencommunicates to the patient. For example, the portable reader can soundan alarm at the end of the dwell or count down a timer, so that thepatient can know during dwell how much time remains before drain.

The processing and memory also store data for each day's treatment, suchas the solution used, how many bags or total volume and pre- andpost-therapy patient weight, blood pressure, blood glucose levels, andtherapy dwell times. In a first primary embodiment, the patient bringsthe portable reader to the doctor's or clinician's office every month orperiodically. At the office the data from the portable reader isdownloaded to the clinician's/doctor's computer, e.g., via (i) wirelesscommunication, in which case the portable reader also includes awireless communication (e.g., Bluetooth™) emitter, or (ii) by pluggingthe portable reader into the clinician's computer, in which case theportable reader can include a connector (e.g., retractable) for acomputer port (e.g., universal serial bus (“USB”) port).

In a second primary embodiment, the portable reader records the dialysissolution bag and sends data wirelessly to the patient's cellular phone,personal electronic mail device or combined device (referred to hereincollectively as a personal communication device (“PCD”)). The weightscale sends patient weight data wirelessly to the personal communicationdevice. The PCD includes processing and memory to calculate the optimaldwell. The cellular phone can notify the patient when it is time fordrain or send a signal back to the portable reader to alert the patientas described above. In a variation of this second embodiment, theportable reader accepts both solution and weight scale data and storesthe algorithm necessary to determine the optimal dwell. The portablereader sends appropriate data wirelessly to the PCD. The PCD downloadsthe appropriate data to the doctor's/clinician's computer and/or to asupply ordering service on a periodic basis, e.g., daily, for patienttherapy tracking. Communication between the personal communicationdevice and the doctor's/clinician's computer can be via satellite, e.g.,via text message.

In a third primary embodiment, a base station replaces the PCD of thesecond primary embodiment. Again, the weight scale data, blood pressure,and blood glucose levels can be sent wirelessly to the base station orto the portable reader. One of the base station or the portable readerincludes processing and memory configured to determine the optimal dwelltime. In one embodiment, the base station signals the portable reader toalert the patient of the optimal dwell time. The base stationcommunicates the appropriate data to the doctor's/clinician's computerperiodically, e.g., daily. Communication between the base station andthe doctor's/clinician's computer and, if desired, a supply orderingservice, can be via an internet connection. The base station can alsoserve to charge the portable reader, and thus it is contemplated to havecommunication between the portable reader and the base station be viadirect computer, e.g., via USB link.

In a fourth primary embodiment, the patient's PCD replaces the portablescanner of the first three primary embodiments. The personalcommunication device uses a built-in camera to (i) scan the bag markingand (ii) receive weigh scale data, blood pressure, blood glucose level,bioimpedance measurement, e.g., wirelessly. The PCD communicates theoptimal dwell or start drain time to the patient by sounding an alarm,vibrating, providing a visual countdown or some combination thereof. Thepersonal communication device sends therapy log information to thedoctor's/clinician's computer and/or a supply ordering service, e.g.,via satellite communication, e.g., daily.

It is contemplated that the systems and methods described herein be usedwith automated peritoneal dialysis (“APD”), however, APD machinestypically control the dwell time and begin drain automatically. Thetherapy login feature is still applicable however, and, many patientswho use APD still perform midday exchanges, for which optimal dwelltimes can be controlled as described above. Moreover, peritonealdialysis or continuous ambulatory peritoneal dialysis (“CAPD”) is stillused by many patients and is one primary modality envisioned for thesystems and methods herein described. If the CAPD therapy uses multiplebags, it is contemplated that the patient scan each bag prior to use toensure that the proper bag is matched with the proper dwell time.

The present disclosure also includes multiple embodiments for therapydownloading and supply ordering systems and methods. Here, the doctor,nurse or clinician can determine a preferred therapy prescription forthe patient and send the prescription to the server. The servermanipulates the selected prescription into a bill of lading having therequisite supplies, e.g., solution type and volume amount, to enablepatient 12 to perform the prescribed therapy. The server sends the billof lading to a warehouse computer of a warehouse storing the supplies. Adelivery person receives the supplies from the warehouse and deliversthe supplies to the patient. The patient in turn uses one of thecommunication devices described herein to inform the server as to howmany of the patient's stock of supplies have been used. This feedback ofsupply consumption information from the patient to the server enablesthe server to generate the bill of lading so as to only deliver thesolution bags and other supplies that the patient actually needs beforethe next delivery is made.

The server knowing the amount of supplies that the patient has actuallyused also allows the doctor, nurse or clinician to access the feedbackdata from the patient to evaluate the patient's compliance with theprescribed therapy. In a slight alternative embodiment, the deliveryperson also has a communication device that is used to communicate withthe server the amount of supplies that are actually delivered to thepatient.

It is accordingly an advantage of the present disclosure to optimizeperitoneal dialysis (“PD”) dwell times.

It is a further advantage of the present disclosure to provide aconvenient and portable device that enables a patient to optimizehis/her PD therapy.

It is another advantage of the present disclosure to provide therapy logdata to a doctor or clinician to optimize a PD therapy over a longerterm.

It is yet another advantage of the present disclosure that supplyordering can be automated via a periodic communication of dialysateconsumption to a supply ordering and inventory tracking system.

It is still a further embodiment of the present disclosure to be able toreadily monitor the patient's compliance with prescribed therapy.

Additional features and advantages are described herein, and will beapparent from the following Detailed Description and the figures.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1A is a schematic illustration of one embodiment of a local therapyoptimization system and method of the present disclosure.

FIG. 1B is a schematic illustration of one embodiment of an integratedtherapy optimization system and method of the present disclosure.

FIG. 2 is a schematic illustration of a second embodiment of a localtherapy optimization system and method of the present disclosure.

FIG. 3 is a schematic illustration of a third embodiment of a localtherapy optimization system and method of the present disclosure.

FIG. 4 is a schematic illustration of a fourth embodiment of a localtherapy optimization system and method of the present disclosure.

FIG. 5 is a schematic illustration of one embodiment of a therapyprescription downloading and ordering system and method of the presentdisclosure.

FIG. 6 is a schematic illustration of a second embodiment of a therapyprescription downloading and ordering system and method of the presentdisclosure.

DETAILED DESCRIPTION

Referring now to the drawings and in particular to FIG. 1, oneembodiment of the therapy optimization system and method is illustratedby system 10 a. System 10 a involves the interaction between a patient12 and a doctor, nurse or clinician 14 (referred to herein collectivelyas medical professional 14). In any of the systems discussed herein, thepatient performs a peritoneal dialysis (“PD”) treatment, which can be anautomated peritoneal dialysis (“APD”) therapy or a manual PD therapy,which is sometimes called a continuous ambulatory peritoneal dialysis(“CAPD”). APD typically programs automated dwell times, such that thepatient drains occur automatically, enabling the patient to sleepthrough the bulk of the PD therapy. Nevertheless, many APD treatmentsalso involve midday exchanges that can take advantage of systems andassociated methodology set forth herein. Even for the automated nightexchanges, however, APD patients can use the information log featuresset forth herein. Certainly, the systems set forth herein are entirelyapplicable to CAPD.

Regardless of whether APD or CAPD is used, the PD treatment typicallyinvolves one or more bags or containers 16 of fresh dialysate. Baggeddialysate can be provided in different varieties. For example, theassignee of the present disclosure markets bagged dialysate under thetrade names Dianeal™, Dianeal-N™, Physioneal™, Extraneal™, andNutraneal™. The dialysates differ in chemical composition and inparticular dextrose level. A higher dextrose level dialysate pulls morewater or ultrafiltration (“UF”) off of the patient. The higher dextroselevel dialysate, however, has a higher caloric content, such that abalance is typically struck for the patient between how much effluentwater the patient needs to remove over the treatment versus how muchweight gain the patient may incur due to the dextrose level.

Dialysate container 16 can also vary in volume, such as being providedin one, 1.5, two, and 2.5 liter bags. Dialysate container 16 can becompletely premixed in a single chamber or be separated into componentsin a dual or multi-chamber bag separated by a seal that patient 12breaks to mix the components prior to treatment. All of the abovevariables, including chemical composition, dextrose level and containervolume affect how long the dialysate should optimally be allowed todwell within the patient. That is, a higher dextrose level dialysateshould be allowed to reside longer within the patients peritoneum to useits full osmotic potential. Also, a larger volume of fresh dialysatewill also have more potential to remove solutes and excess water, andtherefore should be allowed to remain in the patient's peritoneumlonger.

Dialysate container or bag 16 can be provided accordingly with a markeror barcode 18, which designates at least one of dialysate composition,dextrose level and container solution volume. System 10 a also includesa patient scale 20, which the patient uses to weigh himself or herself.The tracking of the patient's weight assists the physician in monitoringthe patient's weight trends, which may result in a prescription change,for example if the patient appears to be gaining weight from thetherapy. Scale 20 is included with electronics in and particular awireless emitter 22 for emitting a signal indicative of the weight ofpatient 12. One suitable scale having a wireless output and system foraddressing and accessing same is disclosed in U.S. patent applicationSer. No. 12/469,371 (“'371 application”), now U.S. Pat. No. 8,282,829,entitled “System and Method for Automated Data Collection of 24 HourUltrafiltration and Other Patient Parameters Using Wired or WirelessTechnology”, filed May 20, 2009, assigned it to the assignee of thepresent disclosure, the entire contents of which are incorporated byreference herein and relied upon. Wireless emitter 22 may use a knownwireless communication technology, such as Bluetooth™, ZigBee™, or otherprotocol, e.g., one based on IEEE 802.

System 10 a further includes a portable reader 30 a, which can be formedas a key ring 32 or worn on a necklace 34. Portable reader 30 a includesa housing 36, which can be formed via plastic injection molding. Housing36 houses an optical scanner 38, such as a laser scanner, which readsmarking or barcode 18 placed on solution bag or container 16. In oneembodiment, when patient 12 holds portable reader 30 a close enough tomarking 18, patient 12 presses an input device 40, which causes scanner38 to read marking 18. Alternatively, scanner 38 reads marking 18automatically when marking 18 is within range of portable reader 30 a.

Portable reader 30 a also includes a wireless receiver 42, which acceptsa wireless weight signal from wireless emitter 22 of weight scale 20.One suitable protocol and addressing system for enabling wirelessreceiver 42 to accept a weight signal from wireless emitter 22 isdiscussed above in the '371 application.

Housing 36 of portable reader 30 a is further fitted with processing 44and memory 46, which receive and store the marking information fromscanner 38. Processing 44 and memory 46 are configured to in turnlook-up and store solution data (e.g., chemical composition, dextroselevel and volume) that is particular to a particular marking or barcode18. Processing 44 and memory 46 are further configured to accept theweight data received at wireless receiver 42 and store such data inmemory 46.

Processing 44 and memory 46 store an algorithm that uses the solutiondata and the patient specific data to determine an optimal dwell timefor patient 12 using fresh dialysate from container 16. One suitablealgorithm for determining the optimal dwell time is to generate apatient specific time to achieve maximum ultrafiltration, urea removalor creatinine removal. All fluid and toxin (urea and creatinine) vs.dwell time curves have a maximum value at a certain dwell time. Thecurves can be generated from kinetic modeling (e.g. using PD Adequest™provided by the assignee of the present disclosure) by varying patients'transporter types, body surface area, type of solution, and fill volume.The maximum fluid and toxin removal values and related optimum dwelltimes can be recorded in look-up tables and are stored in memory 46 thatcross references patient gender, weight (for calculating body surfacearea), fill volume, type of transporter and type of solution. Suitablealgorithms for determining optimal dwell times is disclosed in copendingU.S. patent application Ser. No. 12/431,458, U.S. Publication No.2009/0275881, entitled, “Optimizing Therapy Outcomes For PeritonealDialysis”, filed Apr. 28, 2009, assigned to the assignee of the presentdisclosure, the entire contents of which are incorporated herein byreference and relied upon.

Housing 36 of portable reader 30 a is further outfitted with an outputdevice 48, such as an audio output, a light or flashing light (e.g.,light emitting diode (“LED”)) or display, such as a liquid crystaldisplay (“LCD”). Output device 48 communicates the optimal dwell timedetermined by processing 44 and memory 46 to the patient 12.Communication of the optimal dwell time can be via an alert or alarmwhen dwell has been completed. Alternatively, a display, e.g., LCDdisplay, shows a countdown of remaining dwell time, such that patient 12can gage how long the current dwell is from completion. It iscontemplated for device 48 (for this and any of the embodimentsdiscussed herein) to communicate information visually, audibly,tactilely and any combination thereof.

In one embodiment, processing 44 and memory 46 determine a dwellduration. It is therefore necessary to know when the beginning of dwelloccurs, so that a clock or timer can begin to run. In one embodiment,housing 36 of portable reader 30 a includes a start dwell input device50, which communicates electrically with processing 44, and whichpatient 12 presses as soon as filling from dialysate container 16 to thepatient's peritoneum has been completed. Pressing input device 50signals to processing 44 and memory 46 that the dwell has begun. A timeror counter then begins to run, and output device 48 is activated to showa count down and/or is activated upon completion of the optimized dwellto inform the patient to begin draining the spent dialysis fluid formthe patient's peritoneal cavity.

The PD therapy, and in particular a CAPD therapy, may involve thepatient connecting to and disconnecting from multiple containers 16 offresh dialysate manually. It is contemplated in one embodiment to havepatient 12 read the appropriate marking 18 of each container 16 ofdialysate just before that container is to be used. In this way, theoptimal dwell time is determined and known for each container 16 justprior to its use. It is also contemplated, especially in instances inwhich the same dialysate type and volume is to be used multiple times inthe same therapy, to enable patient 12 to scan each container 16 at thebeginning of therapy, such that the patient does not have to scan acontainer 16 between each fill. It is quite likely than that the optimaldwell time will be the same for each container 16, such that patient 12does not have to keep track of which container 16 has been scannedfirst, second, third, and so on. If containers 16 contain differenttypes or volumes or fresh dialysate, portable reader 30 a can determinesame and inform the patient that a particular container 16 needs to beused in the order in which it has been scanned.

In one embodiment, patient 12 weights himself or herself on scale 20prior to each fill and weighs the drain volume. From these data, UFtrending can be done for both CAPD and APD patients. Using the UFtrending, clinicians may check the patients compliance and potentiallychange solution to optimize the therapy such that the algorithm used inprocessing 44 and of memory 46 begins with a most current patient weightin determining the optimal dwell just prior to each patient fill.

In an alternative embodiment in which patient 12 is not able to scanmultiple containers 16 at the beginning of therapy, the patient's weightloss after each patient drain can be estimated using another algorithm,such that a new weight can be entered for each optimized dwellcalculation or determination. The algorithm can for example use acertain percentage of the fill volume as the estimated UF removed overthat cycle. For example, the percentage can be eight percent of the fillvolume. The percentage is in one embodiment determined on a patientspecific basis.

Instead of a separate algorithm, processing 44 and memory 46 can furtheralternatively estimate or empirically determine the weight loss of thepatient given the patient's beginning weight, total target weight loss,solution type and volume used over the previously optimized dwell time.

Referring now to FIG. 1B, one embodiment for downloading loggedinformation from portable reader 30 a of system 10 a to a medicalprofessional 14 for long term therapy optimization is illustrated. Inone implementation, wireless receiver 42 is a wireless transceiver,e.g., using Bluetooth™, ZigBee™, or other wireless protocol, e.g., basedon IEEE 802, which not only receives wireless information but alsotransmits wireless information. In the illustrated embodiment, patient12 brings portable reader 30 a to the office of the medical professional14. As soon as portable reader 30 a is placed within wirelesscommunication range of the medical professional's computer 52, portablereader 30 a automatically downloads the information read from weightscale 20, solution container 16 and information determined at portablereader 30 a for each container used over a period of time, such as amonth or whatever the period exists between visits to medicalprofessional 14.

In a further implementation, portable reader 30 a includes a connector(not shown). In the operational position, the connector can be pluggedinto a port, such as a universal serial bus (“USB”) port, of the medicalprofessional's computer 52. The above described information is thendownloaded to the computer. Once on the computer, medical professional14 can review the results and change the patient's therapy prescriptionif needed. FIGS. 1A and 1B for system 10 a accordingly illustrate thatsystem 10 a optimizes therapy on a local or daily basis and over anintegrated basis spanning a period of time. It should be appreciatedthat in the illustrated embodiment, communication in system 10 a takesplace wirelessly over a local wireless network, both in the environmentof patient 12 and medical professional 14 (which can alternatively belocal wired communication).

Referring now to FIG. 2, an alternative system 10 b is illustrated.System 10 b includes many of the features of system 10 a, which arenumbered the same accordingly, such as scale 20 having wireless emitter22, solution container 16 having marking or barcode 18 and medicalprofessional computer 52. An alternative portable reader 30 b isprovided, which can again be provided on a key ring 32, as a key foband/or worn on a necklace 34 on patient 12.

Portable reader 30 b includes scanner 38 that reads marking 18 eitherautomatically or upon an activation of input 40, as described above. Inone implementation, portable reader 30 b includes processing 44 andmemory 46, which again are housed in housing 36. In one implementation,local wireless receiver or transceiver 42 is replaced with a localwireless emitter 54, which can be the same or similar to emitter 22located within scale 20. Emitter 22 sends a wireless weight signal tothe patient's cellular phone or portable email device (referred toherein and collectively as a personal communication device (“PCD”)) 60.Likewise, wireless emitter 54 of portable reader 30 b emits a wirelesssignal representing solution data, as described above, to PCD 60. PCD 60can be configured to calculate the optimal dwell time using the abovedescribed algorithm or via an empirical method. PCD 60 includes adisplay device 62, multiple input devices 64 and a speaker 66. One orboth of video screens 62 and speaker 66 can be used as an output device,which communicates the optimal dwell time to patient 12. For example,display 62 can show a countdown of the optimal dwell time to patient 12,so that the patient knows how much longer the optimized dwell willcontinue. Alternatively or additionally, PCD 60 calls patient 12 viaspeaker 66 when it is time for the patient to drain the spent dialysateat the end of the optimized dwell period. In an alternativeimplementation, wireless emitter 54 is a wireless transceiver, which canreceive a wireless signal from PCD 60, telling portable reader 30 b toprovide an audible and/or visual output to patient 12.

In yet another alternative embodiment, portable reader 30 a (shown anddescribed in connection with FIG. 1A) is used with system 10 b insteadof portable reader 30 b. All of the optimal dwell time computations arethen performed on portable reader 30 a, which then sends the optimaldwell time and any other desired information to PCD 60 for communicationwith the medical professional's computer 52.

System 10 b, like system 10 a also provides a long term therapyoptimization feature, which involves communication between PCD 60 andmedical professional's computer 52. In an embodiment, on a periodicbasis, such as daily or otherwise according to an application stored onPCD 60, PCD 60 sends a text or satellite message to the medicalprofessional's computer 52, downloading any of the pertinent datadescribed above in connection with system 10 a. The information allowsmedical professional 14 to evaluate the patient's therapy performanceover time and make PD prescription changes if necessary. It is thereforecontemplated that the portable reader 30 b communicates with PCD 60 on afirst periodic basis, e.g., after each reading taken by reader 30 b, andthat PCD 60 communicates with the medical professional's computer 52 ona second periodic basis, e.g., daily.

Referring now to FIG. 3, an alternative system 10 c is illustrated.System 10 c includes many of the features of systems 10 a and 10 b,which are numbered the same accordingly, such as scale 20 havingwireless emitter 22, solution container 16 having marking or barcode 18and medical professional computer 52. Portable reader 30 a is provided,which can again be provided on a key ring 32, as a key fob and/or wornon a necklace 34 on patient 12. As before, portable reader 30 a includesscanner 38 that reads marking 18 either automatically or upon anactivation of input 40, as described above. Portable reader 30 a isshown here including processing 44 and memory 46, which again are housedin housing 36, however, processing 44 and memory 46 may not be neededbecause the dwell calculations are done at base station 70 discussedbelow. Portable reader 30 a includes local wireless transceiver 42, toreceive optimal dwell information from base station 70 for communicationto patient via output device 48.

Base station 70 includes a wireless transceiver 72, which receives awireless weight signal from transmitter 22 of weight scale 20 and any ofthe above-described solution data from transceiver 42 of portable reader30 a. Wireless transceiver 72 communicates dwell data to wirelesstransceiver 42 of portable reader 30 a to provide an audible and/orvisual output to patient 12.

Base station 70 includes processing 72 and memory 74 configured tocalculate the optimal dwell time using the above described algorithm orvia an empirical method. Base station 70 can include a display device78, multiple input devices 80, and a speaker 82 if needed. One or bothof video screens 78 and speaker 82 can be used, in addition to outdevice 48 of portable reader 30 a, as an output device to communicatethe optimal dwell time to patient 12. For example, device 48 and display78 can show a countdown of the optimal dwell time to patient 12, so thatthe patient knows how much longer the optimized dwell will continue.Alternatively or additionally, speaker 82 and/or device 48 alertspatient 12 when it is time for the patient to drain the spent dialysateat the end of the optimized dwell period.

Base station 70 also includes a docking area 84 for holding portablereader 30 a, charging portable reader 30 a, and possibly downloadinginformation from and importing information to portable reader 30 a, suchthat transceiver 42 of portable reader 30 a may be replaced with a USBor other type of connector that is received by a data communication portat docking area 84 of base station 70.

System 10 c, like systems 10 a and 10 b also provides a long termtherapy optimization feature, which involves communication between basestation 70 and medical professional's computer 52. In an embodiment, ona periodic basis, such as daily or otherwise according to an applicationstored on base station 70, base station 70 sends a communication, e.g.,via an internet connection, to the medical professional's computer 52,downloading any of the pertinent data described above in connection withsystem 10 a. The information allows medical professional 14 to evaluatethe patient's therapy performance over time and make PD prescriptionchanges if necessary. It is therefore contemplated that the portablereader 30 a communicates with base station 70 on a first periodic basis,e.g., after each reading taken by reader 30 a, and that base station 70communicates with the medical professional's computer 52 on a secondperiodic basis, e.g., daily.

Referring now to FIG. 4, an alternative system 10 d is illustrated.System 10 d includes many of the features of systems 10 a, 10 b and 10c, which are numbered the same accordingly, such as scale 20 havingwireless emitter 22, solution container 16 having marking or barcode 18and medical professional computer 52. personal communication device(“PCD”) 90 is provided, which can be worn on a necklace 34 on patient 12but is most likely carried by the patient. Here, PCD 90 includes acamera 94 that takes a picture of marking 18 either automatically orupon an activation of an input 96. PCD 90 in one embodiment is a smartphone, such as a iPhone™, Blackberry™ or other similar device which canhave electronic mail and store various software applications. PCDincludes a local wireless transceiver 92 to received a wireless weightsignal from transmitter 22 of weight scale 20. PCD 90 includesprocessing 98 and memory 100 that are configured to run software thatconverts the barcode picture into digital data.

One suitable software is QuickMark, provided by SimpleAct, Inc., 6F.,No. 24, Cingchen St., Songshan District, Taipei City, 105 Taiwan(R.O.C.), Telephone No. 886-2-87706690. The software uses the digitaldata in a look-up table to determine any of the solution informationdescribed above, such and type, volume, dextrose level, and chemicalconcentration. Processing 98 and memory 100 as further configured tocalculate the optimal dwell time using the above described algorithm orvia an empirical method using the patient weight and solution data.

PCD 90 includes a display device 102, multiple input devices 96, and aspeaker 104 if needed. One or both of video screen 102 and speaker 104can be used as an output device to communicate the optimal dwell time topatient 12. For example, display 102 can show a countdown of the optimaldwell time to patient 12, so that the patient knows how much longer theoptimized dwell will continue. Alternatively or additionally, speaker104 alerts patient 12 when it is time for the patient to drain the spentdialysate at the end of the optimized dwell period.

System 10 d, like systems 10 a to 10 c also provides a long term therapyoptimization feature, which involves communication between PCD 90 andmedical professional's computer 52. In an embodiment, on a periodicbasis, such as daily or otherwise according to an application stored onPCD 90, PCD 90 sends a communication, e.g., via a satellite textprotocol, to the medical professional's computer 52 and/or supplyreordering system, downloading any of the pertinent data described abovein connection with system 10 a. The information allows medicalprofessional 14 to evaluate the patient's therapy performance over timeand make PD prescription changes if necessary. System 10 d is desirablein one respect because a separate portable reader is not needed. PCD 90,which patient 12 uses for other purposes, such as personal email, phoneusage, media storage, is also used for the optimization of the patient'sdialysis therapy.

Referring now to FIG. 5, system 110 a illustrates one suitable therapyprescription downloading and supply ordering system using PCD 60, PCD 90or portable reader 30 a, 30 b or 30 c discussed above. In theillustrated embodiment PCD 90 is shown, which includes all of thefeatures and alternatives discussed above for PCD 90. In a first step ofthe method or facet of system 110 a, medical professional 14communicates with central server 120, e.g., via a web browser andcomputer. Server 120 can be a server maintained by the company thatprovides solution bags 16 or by a company contracted by the solution bagcompany. Medical professional 14 enters patient specific information,such as gender, height, weight, transport type, and fill volume, intothe doctor's web browser located at computer 52, which can run a therapyprediction software, such as one described in U.S. patent applicationSer. No. 12/170,184, entitled, “Dialysis System Having RegimenGeneration Methodology”, filed Jul. 9, 2008, assigned to the assignee ofthe present disclosure, the entire contents of which are incorporatedherein by reference. The prediction software presents medicalprofessional 14 with one or more recommendations for a therapyprescription. The software allows the medical professional 14 to acceptor modify the prescription. Medical professional 14 issues a “program”command via the browser, which causes server 120 to automatically andremotely program PCD 90 with the desired therapy prescription. Thecommunication from PCD 90 to server 120 can be a one time communicationor communication that occurs periodically after medical professional 14reevaluates patient 12.

In a second step of the method or facet of system 110 a, server 120communicates the medical professional's 14 prescription to a warehousecomputer 116 located at a warehouse of the manufacturer of the solutionand solution bags 16. The communication from server 120 to warehousecomputer 116 can be transparent or done automatically whenever medicalprofessional 14 changes the therapy prescription for patient 14.Warehouse computer 116 generates a supply order, e.g., a bill of lading.

In a third step of the method or facet of system 110 a, warehousecomputer 116 sends or prepares the bill of lading to/for delivery person112, which is done on a periodic basis, such as once a month. In afourth step of the method or facet of system 110 a, delivery person 112obtains the necessary supplies, e.g., solution bags 16, connectors,etc., and delivers the supplies to patient 12, which is also done on aperiodic basis, such as once a month. It should be appreciated thatsteps one to four allow central server 120 to track the amount ofsupplies delivered from warehouse 116.

In a fifth step of the method or facet of system 110 a, patient 12 usesPCD 90 to scan barcodes off of solution bags 16. PCD 90 receives patientdata for patient 12, such as patient weight, blood pressure and bloodglucose levels, as discussed above. At one or more, e.g., predeterminedor patient selected time of the day, PCD 90 communicates the bag scan(or other supply usage data) and patient data to a central server 120.The communication from PCD 90 to server 120 is in one embodimentautomatic and transparent to patient 12. It should be appreciated thatstep five allows server 120 to know how much of the supplies or solutionbags 16 delivered to patient 12 have actually been used by the patient.Knowing how many supplies have been delivered from the warehouse housingcomputer 116 and how many supplies have been used by patient 12, system110 a at server 120 can determine when to deliver and how many suppliesor solution bags 16 to deliver to patient 12. And as discussed, server120 orders supplies or patient 12 based on the therapy prescription sentfrom medical professional 14.

Knowing how many supplies have been used by patient 12 also enablesmedical professional 14 to track the patient's compliance with theprescribed therapy. If patient 12 is supposed to use twenty solutionbags 16 of dialysate per week, but PCD 90 consistently reports back thatthe patient is using less than twenty bags, medical professional 14 uponviewing this compliance data, e.g., at computer 52, can contact patient12 to inquire as to why the patient's prescription is not beingfollowed. Or, the compliance data can be discussed the next time patient12 visits medical professional 14. To this end, it is contemplated formedical professional 14 to be able to access patient therapy compliancedata from server 120 and/or for server 120 to periodically send patienttherapy compliance data reports to computer 52 of medical professional14. The report in one embodiment is copied to PCD 90 and patient 12, sothat patient 12 knows that medical professional 14 is seeing thepatient's compliance reports, good or bad.

Referring now to FIG. 6, system 110 b illustrates another suitabletherapy prescription downloading and supply ordering system using PCD60, PCD 90 or portable reader 30 a, 30 b or 30 c discussed above. System110 b includes all of the steps and alternatives discussed above forsystem 110 a of FIG. 5. In an additional step or facet of system 110 b,delivery person 112 is provided with a handheld device, such as PCD 60or PCD 90, which enables delivery person 112 to report back to server120 how many supplies, such as supply bags 16, have actually beendelivered to patient 12. System 110 b closes the loop between server120, warehouse computer 116 and driver 112. Unlike system 110 a, whichassumes all supplies listed on the bill of lading are delivered topatient 12, system 110 b allows server 120 to receive the amount ofsupplies actually delivered from delivery person 112 to patient 12. Thisinformation in combination with the amount of supplies used sent frompatient PCD 90 enables server 120 to know when and how many supplies,such as solution bags 16 to order for the patient 12.

It should be understood that various changes and modifications to thepresently preferred embodiments described herein will be apparent tothose skilled in the art. Such changes and modifications can be madewithout departing from the spirit and scope of the present subjectmatter and without diminishing its intended advantages. It is thereforeintended that such changes and modifications be covered by the appendedclaims.

The invention is claimed as follows:
 1. A handheld personalcommunication apparatus for a continuous ambulatory peritoneal dialysis(“CAPD”) treatment comprising: a reader configured to perform at leastone of (i) read a marking displayed on a dialysis fluid container toacquire data concerning at least one of a dialysis fluid type or adialysis fluid volume from the marking, or (ii) receive a patient weightsignal from a weight scale; a processor configured to use the at leasttwo of the dialysis fluid type, the dialysis fluid volume, or thepatient weight signal to determine a dialysis dwell time for a dialysisdwell of a single CAPD cycle of a dialysis therapy for a patient, thedialysis dwell time corresponding to a time to achieve at least one of(a) a specified ultrafiltrate level for the CAPD cycle, (b) a urearemoval level for the CAPD cycle, or (c) a creatinine removal level forthe CAPD cycle, begin a timer upon a start of the dialysis dwell, andafter the timer has reached the dialysis dwell time, transmit an outputsignal; and an output interface configured to, in response to the outputsignal, provide an indication to the patient of a completion of thedialysis dwell time, wherein the indication includes at least one of (i)a display of a visual notification on a screen of the output interface,(ii) an audio notification via a speaker of the output interface, or(iii) a tactile actuation via an actuator of the output interface. 2.The handheld apparatus of claim 1, further comprising a transceiverconfigured to transmit at least one of the dialysis fluid type, thedialysis fluid volume, or the patient weight signal to a remotelylocated computer to enable the computer to use at least one of thedialysis fluid type, the dialysis fluid volume, the weight signal, orthe dwell time to track a therapy progress of the patient.
 3. Thehandheld apparatus of claim 2, wherein the transceiver is configured toreceive a dialysis prescription from the computer and cause the outputinterface to display the dialysis prescription to the patient.
 4. Thehandheld apparatus of claim 3, wherein the processor is configured tomodify the dialysis therapy based on the received dialysis prescription.5. The handheld apparatus of claim 2, wherein at least one of theprocessor and the output interface is housed with the reader.
 6. Thehandheld apparatus of claim 1, wherein the reader includes (i) a barcodescanner, the marking displayed on the dialysis fluid container being abarcode, (ii) a radio frequency identification (“RFID”) reader, themarking displayed on the dialysis fluid container being an RFID tag, or(iii) a camera of a smart phone.
 7. The handheld apparatus of claim 1,wherein the reader includes a wireless receiver to wirelessly receivethe patient weight signal from the weight scale.
 8. The handheldapparatus of claim 1, which is a smartphone.
 9. A dialysis device for acontinuous ambulatory peritoneal dialysis (“CAPD”) treatment comprising:a handheld housing; processor and memory located within the housing; areader included within the housing and in communication with theprocessor, the reader configured to read a marking displayed on adialysis fluid container to acquire solution data concerning at leastone of a dialysis fluid type or a dialysis fluid volume from themarking; a transceiver included within the housing and in electricalcommunication with the processor, the transceiver configured to receivepatient data from a medical sensor; wherein the processor operating withthe memory and the reader and/or the transceiver is configured to use atleast two of the dialysis fluid type, the dialysis fluid volume, or thepatient data to determine a dialysis dwell time for a dialysis dwell ofa single CAPD cycle of a dialysis therapy for the patient, the dialysisdwell time corresponding to a time to achieve at least one of (a) aspecified ultrafiltrate level for the CAPD cycle, (b) a urea removallevel for the CAPD cycle, or (c) a creatinine removal level for the CAPDcycle, begin a timer upon a start of the dialysis dwell, and after thetimer has reached the dialysis dwell time, transmit an output signal;and an output interface carried by the housing and configured to, inresponse to the output signal, provide an indication to a patient of acompletion of the dialysis dwell time, wherein the indication includesat least one of (i) a display of a visual notification on a screen ofthe output interface, (ii) an audio notification via a speaker of theoutput interface, or (iii) a tactile actuation via an actuator of theoutput interface.
 10. The dialysis device of claim 9, further comprisinga start dwell input device configured to receive an input from thepatient for beginning the timer.
 11. The dialysis device of claim 10,wherein the start dwell input device is provided by the outputinterface.
 12. The dialysis device of claim 9, wherein the reader is acamera and the transceiver is wireless.
 13. The dialysis device of claim9, wherein the data is patient weight data.
 14. The dialysis device ofclaim 9, wherein the output interface is configured to provide thedialysis dwell time to the patient in addition to the dialysis dwelltime completion.
 15. The dialysis device of claim 9, which is a smartphone.
 16. A handheld personal communication apparatus for a continuousambulatory peritoneal dialysis (“CAPD”) treatment comprisinginstructions, which when executed, cause the personal communicationapparatus to: instruct a reader to perform at least one of (i) read amarking displayed on a dialysis fluid container to acquire dataconcerning at least one of a dialysis fluid type or a dialysis fluidvolume from the marking, or (ii) receive a patient weight signal from aweight scale; determine, via a processor, a dialysis dwell time for adialysis dwell of a single CAPD cycle of a dialysis therapy for apatient using the acquired data, including the at least two of thedialysis fluid type, the dialysis fluid volume, or the patient weightsignal, the dialysis dwell time corresponding to a time to achieve atleast one of (a) a specified ultrafiltrate level for the CAPD cycle, (b)a urea removal level for the CAPD cycle, or (c) a creatinine removallevel for the CAPD cycle; begin, via the processor, a timer upon a startof the dialysis dwell; after the timer has reached the dialysis dwelltime, transmit, via the processor, an output signal; and instruct, viathe processor in response to the output signal, an output interface toprovide an indication to the patient of a completion of the dialysisdwell time.
 17. The handheld personal communication apparatus of claim16, further comprising instructions, which when executed by theprocessor, cause the personal communication apparatus to: receive acontainer indication that a new dialysis fluid container is to be used;instruct the reader to read a marking displayed on the new dialysisfluid container to acquire second data concerning at least one of thedialysis fluid type or the dialysis fluid volume from the marking;determine, via the processor, a second dialysis dwell time for at leastone cycle of the dialysis therapy for the patient using the acquiredsecond data, or the patient weight signal; and instruct the outputinterface to provide a second indication to the patient of a completionof the second dialysis dwell time.
 18. The handheld personalcommunication apparatus of claim 16, further comprising instructions,which when executed by the processor, cause the personal communicationapparatus to: receive an indication that each of a plurality of dialysisfluid containers has a same dialysis fluid volume; instruct the readerto read a marking displayed on each of the dialysis fluid containers toacquire data concerning at least one of the dialysis fluid type or thedialysis fluid volume from the respective marking; and instruct theoutput interface to provide the indication to the patient of thecompletion of the dialysis dwell time for each dialysis fluid container.19. The handheld personal communication apparatus of claim 16, furthercomprising instructions, which when executed by the processor, cause thepersonal communication apparatus to: receive an indication that each ofa plurality of dialysis fluid containers has at least one of a differentdialysis fluid volume or different dialysis fluid type; instruct thereader to read a marking displayed on each of the dialysis fluidcontainers to acquire the data concerning at least one of the dialysisfluid type or the dialysis fluid volume from the respective marking;determine, via the processor, the dialysis dwell time for each of thedialysis fluid containers using the respective acquired data, includingthe at least one of the dialysis fluid type or the dialysis fluidvolume; instruct the output interface to provide an indication to thepatient regarding which of the dialysis fluid containers should be used;and instruct the output interface to provide the indication to thepatient of the completion of the dialysis dwell time for the specifieddialysis fluid container.
 20. The handheld personal communicationapparatus of claim 16, further comprising instructions, which whenexecuted by the processor, cause the personal communication apparatusto: instruct the reader to receive the patient weight signal from theweight scale before each fill of the dialysis fluid; determine, via theprocessor, an ultrafiltration trend based on multiple patient weightsignals for multiple fills; and instruct the output interface to displaythe ultrafiltration trend.
 21. The handheld personal communicationapparatus of claim 20, wherein the patient weight signals include atleast one of an actual patient weight or a weight of a dialysis fluiddrain volume.